Needle and related methods

ABSTRACT

An optical spectroscopic injection needle assembly. According to one embodiment, the assembly may include an injection needle, a light source, a spectrometer, a computer and an indicator. The injection needle, in turn, may include a hollow outer needle, a hollow inner needle, a pair of optical fibers, an inner catheter, an outer catheter, an inner hub and an outer hub. The proximal end of the outer needle may be fixedly mounted within the distal end of the inner catheter. The distal end of the inner hub may be fixedly mounted on the proximal end of the inner catheter, the proximal end of the inner hub being suited for connection to a syringe. The inner needle, as well as the distal ends of the optical fibers, may be positioned within the outer needle and may be held in place by an optical bonding material. The proximal ends of the optical fibers may extend from a side arm of the inner hub, one fiber may be coupled to the light source, the other fiber may be coupled to the spectrometer. The inner catheter and the outer needle may be slidably mounted within the outer catheter to permit the outer needle to be selectively extended or retracted from the distal end of the outer catheter. The outer hub may be fixedly mounted on the proximal end of the outer catheter. In use, as the outer needle may be inserted into a tissue, the tissue may be illuminated and the reflected light may be detected and compared to standards for various tissue types. The results of the comparison may then be indicated.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit under 35 U.S.C. 119(e) ofU.S. Provisional Patent Application Ser. No. 60/819,586, filed Jul. 10,2006, the disclosure of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

The present invention relates generally to injection needles and relatesmore particularly to an injection needle incorporating visualization.

Nearly half of all Americans suffer from heartburn at least once amonth. Heartburn occurs when stomach fluids and acids escape from thestomach and enter into the esophagus, irritating the esophagus.Normally, a muscular ring called the lower esophageal sphincter (LES)acts as a valve between the esophagus and the stomach to allow food topass from the esophagus into the stomach while keeping stomach fluidsand acids from escaping from the stomach into the esophagus. In thoseinstances in which the LES fails to keep stomach fluids and acids in thestomach, heartburn occurs.

For some people who suffer from heartburn, the heartburn is severeenough or frequent enough to disrupt their daily activities and/or theirsleep. Such a condition is called gastroesophageal reflux disease(GERD). In some people who have GERD, the LES relaxes more than itshould and/or at the wrong times.

In addition to causing frequent and/or severe heartburn, GERD can causeother health problems. For example, the fluids and acids that refluxinto the esophagus can lead to inflammation of the esophagus(esophagitis) or ulcers. In severe cases, this damage can scar theesophageal lining and narrow it, causing a stricture which may make ithard or painful for the patient to swallow. In certain cases, this maylead to a condition called Barrett's esophagus, where the lining of theesophagus changes and may over time lead to cancer of the esophagus.

Many people can get relief from GERD symptoms by changing their dietand/or using appropriate medications. Some of the medications availablefor managing GERD symptoms include common antacids as well as drugs thatslow down the production of stomach acids, such as proton pumpinhibitors and H₂ receptor antagonists.

It should be noted, however, that medications of the type describedabove merely address symptoms of GERD and do not address the condition'smechanical etiology. Thus, GERD symptoms often recur after drugwithdrawal. In addition, while medications may effectively treat theacid-induced symptoms of GERD, they do not treat alkaline reflux, whichmay result in esophageal mucosal injury.

In any event, because GERD is a chronic condition, it may be necessaryfor a patient to take medications for the rest of his life in order tocontinue to obtain relief from GERD symptoms. However, for manypatients, the expense and the psychological burden of a lifetime ofmedication dependence, as well as the uncertainty of long-term effectsof some newer medications and the potential for persistent mucosalchanges despite symptomatic control, make surgical treatment an alluringalternative to a medicinal approach. As can readily be appreciated,however, surgical intervention, often in the form of anti-refluxsurgery, is a major undertaking and includes its own set of risks.

Fortunately, a minimally invasive technique has been devised fortreating GERD. This technique, which is more fully disclosed in U.S.Pat. Nos. 6,238,335, 6,251,063, 6,351,064 and 6,695,764, all of whichare incorporated herein by reference, typically involves first insertingan endoscope down through the patient's mouth and into the esophagus inproximity to the LES. Then, the distal end of a device commonly referredto as “an injection needle” is inserted through a working channel of theendoscope, and a needle at the distal end of the injection needle isinserted into the muscle of the LES. Then, a special solution isdispensed through the injection needle and into the muscle of the LES.The solution includes a biocompatible polymer that forms a soft, spongy,permanent implant in the sphincter muscle that helps the LES to keepstomach fluids and acids from backing up into the esophagus.

Typically, an injection needle of the type referred to above comprises ahollow needle, a flexible inner catheter, a flexible outer catheter, aninner hub and an outer hub. The proximal end of the hollow needle istypically fixedly mounted within the distal end of the flexible innercatheter. The inner hub is typically fixedly mounted on the proximal endof the inner catheter and is adapted to convey fluids to the innercatheter from a needleless syringe or the like. The inner catheter andthe hollow needle are typically slidably mounted within the outercatheter so that one may extend the hollow needle out of the distal endof the outer catheter when one wishes to make an injection and retractthe hollow needle into the outer catheter when not making an injection.The outer hub is typically fixedly mounted on the proximal end of theouter catheter and is adapted to engage the inner hub so as to limit thedistal movement of the needle and the inner catheter relative to theouter catheter. Examples of injection needles are disclosed in thefollowing patents, all of which are incorporated herein by reference:U.S. Pat. No. 6,770,053; U.S. Pat. No. 6,585,694; U.S. Pat. No.6,423,034; U.S. Pat. No. 6,401,718; U.S. Pat. No. 6,336,915; U.S. Pat.No. 5,785,689; U.S. Pat. No. 4,946,442; and U.S. Pat. No. 4,668,226.

Typically, certain measures are taken to promote proper placement of thedistal tip of the injection needle in the targeted tissue. For example,where the injection needle is delivered to the patient via the workingchannel of an endoscope, the endoscope is typically additionallyequipped with a light and a camera so that one can view, in real-time,the environs of the distal end of the endoscope; in this manner, thetargeted penetration site may be identified. In addition, to promote aproper penetration depth of the needle into the targeted tissue, theneedle is typically dimensioned to extend from the distal end of theinner catheter by a length corresponding to the desired penetrationdepth. However, as can be appreciated, tissue thicknesses vary frompatient to patient. Moreover, because tissue is easily compressed andbecause tissue may be penetrated by the inner catheter as well as by theneedle, the depth of needle penetration cannot always be controlled bydimensioning the needle in the above manner. For this reason,fluoroscopy is often employed to provide live X-ray images of theinjected solution that indicate if the needle has been inserted too farthrough the tissue.

In addition to being used in the above fashion to treat GERD, injectionneedles are also useful in injecting other treatment materials, such asdrugs, treatments for bleeding, etc.

SUMMARY OF THE INVENTION

According to one aspect of the invention, there is provided an injectionneedle that may comprise (a) a first catheter, said first cathetercomprising a proximal end, a distal end and a longitudinal bore; (b) afirst hollow needle, said first hollow needle being designed to extenddistally from said distal end of said first catheter, said first hollowneedle comprising a distal end adapted for insertion into an object; (c)a tubular member, said tubular member comprising a longitudinal bore,said tubular member being disposed within said first hollow needle, saidlongitudinal bore of said tubular member being in fluid communicationwith said longitudinal bore of said first catheter; and (d) fiber opticswhich may be located within said first hollow needle for transmittinglight to an object and for collecting light reflected from the object.

In another embodiment of the invention, an optical spectroscopicinjection needle assembly may comprise (a) an injection needle, whichmay comprise (i) a first catheter, said first catheter having a proximalend, a distal end and a longitudinal bore; (ii) a first hollow needle,said first hollow needle designed to extend distally from said distalend of said first catheter, said first hollow needle comprising a distalend adapted for insertion into an object; (iii) a tubular member, saidtubular member comprising a longitudinal bore, said tubular member beingdisposed within said first hollow needle, said longitudinal bore of saidtubular member being in fluid communication with said longitudinal boreof said first catheter; and (iv) fiber optics which may be locatedwithin said first hollow needle, in one embodiment, for transmittinglight to an object and for collecting light reflected from the object;(b) means, optically coupled to the fiber optics, and adapted toserially illuminate an object at a plurality of wavelengths; (c) means,optically coupled to the fiber optics, provided to detect the lightreflected from the illuminated object at said plurality of wavelengths;(d) means for comparing the detected light to appropriate standards; and(e) means for indicating the results of said comparison.

In another embodiment of the invention, a method of treating a tissuemay comprise the steps of (a) providing the aforementioned opticalspectroscopic injection needle assembly; (b) inserting the first hollowneedle into an insertion site of a body part to a first depth; (c)illuminating the body part at said first depth, in one embodiment, usinglight transmitted through said fiber optics from said seriallyilluminating means; (d) detecting the light reflected from theilluminated object at said first depth using said detecting means; (e)comparing the detected light to appropriate standards; (f) indicatingthe results of said comparison; (g) if needed, repeating steps (b)through (f) for other depths or other insertions sites until a desiredtissue is located; and (h) injecting a material through the tubularmember and into the desired tissue.

For purposes of the present specification and claims, various relationalterms like top, bottom, proximal, distal, upper, lower, front, and rearare used to describe the present invention when said invention ispositioned in or viewed from a given orientation. It is to be understoodthat, by altering the orientation of the invention, certain relationalterms may need to be adjusted accordingly.

Various objects, features and advantages of the present invention willbe set forth in part in the description which follows, and in part willbe obvious from the description or may be learned by practice of theinvention. In the description, reference is made to the accompanyingdrawings which form a part thereof and in which is shown by way ofillustration various embodiments for practicing the invention. Theembodiments will be described in sufficient detail to enable thoseskilled in the art to practice the invention, and it is to be understoodthat other embodiments may be utilized and that structural changes maybe made without departing from the scope of the invention. The followingdetailed description is, therefore, not to be taken in a limiting sense,and the scope of the present invention is best defined by the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are hereby incorporated into andconstitute a part of this specification, illustrate various embodimentsof the invention and, together with the description, serve to explainthe principles of the invention. In the drawings wherein like referencenumerals represent like parts:

FIG. 1 illustrates a partly schematic side view, broken away in part, ofone embodiment of an optical spectroscopic injection needle assemblyconstructed according to the teachings of the present invention, theassembly being shown with its needle in a retracted position;

FIG. 2 illustrates a partly schematic side view, broken away in part, ofthe optical spectroscopic injection needle assembly of FIG. 1, theassembly being shown with its needle in an extended position;

FIG. 3 illustrates an enlarged fragmentary longitudinal section view ofthe distal end of the optical spectroscopic injection needle assembly ofFIG. 1, the assembly being shown with a needle in an extended position;

FIG. 4 illustrates a fragmentary side view, partly in section, of theproximal end of the optical spectroscopic injection needle assembly ofFIG. 1;

FIG. 5 illustrates an enlarged section view taken along line 1-1 of FIG.2;

FIG. 6 illustrates an enlarged section view of an alternate needleassembly for use in the injection needle of FIG. 1; and

FIGS. 7( a) and 7(b) are enlarged distal end and fragmentary top views,respectively, of the fiber optic assembly illustrated in FIG. 6.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now to FIGS. 1 through 5, there are shown various views of oneembodiment of an optical spectroscopic injection needle assemblyconstructed according to the teachings of the present invention, saidoptical spectroscopic injection needle assembly being representedgenerally by reference numeral 11.

Assembly 11 may include an injection needle 13, a light source 15, aspectrometer 17, a computer 19 and an indicator 21.

Injection needle 13 may comprise a hollow outer needle 31. Outer needle31 may include an elongated, unitary, tubular member of uniformdiameter, made of stainless steel or the like, outer needle 13 may beshaped to include a blunt proximal end 33, a beveled distal end 35 and alongitudinal bore 37. Outer needle 31 may be dimensioned to be, forexample, a 22 gauge extra thin walled hypodermic needle having a bevelof 18 degrees.

Injection needle 13 may also comprise a hollow inner needle 41. Innerneedle 41 may be positioned within bore 37 of outer needle 31. Innerneedle 41 may be an elongated, unitary, tubular member of uniformdiameter, made of stainless steel or the like. Inner needle 41 may beshaped to include a blunt proximal end 43, a beveled distal end 45 and alongitudinal bore 47. Inner needle 41 may be dimensioned to be, forexample, a 25 gauge extra thin walled hypodermic needle having a bevelof 18 degrees. Inner needle 41 may be dimensioned so that blunt proximalend 43 and beveled distal end 45 lie flush with blunt proximal end 33and beveled distal end 35, respectively, of needle 31. As will bediscussed further below, longitudinal bore 47 of inner needle 41 may beused to convey fluids, such as a solution of implant material whereinjection needle 13 is used to inject such a solution into the LESmuscle of a GERD patient. (Alternatively, injection needle 13 may beused to inject therapeutic and diagnostic agents.)

Injection needle 13 may further comprise a pair of optical fibers 49-1and 49-2, the distal ends (not shown) of optical fibers 49-1 and 49-2may be inserted into longitudinal bore 37 of needle 31. In the presentembodiment, fibers 49-1 and 49-2 may be identical to one another and maybe 0.22 NA, step index multimode fibers optimized for the VIS-NIR range,each of fibers 49-1 and 49-2 may include a silica-based core 50 of 100micron diameter, a silica-based cladding 51 of 110 micron diameter, anda polyimide buffer 52 of 125 micron diameter. The distal ends (notshown) of fibers 49-1 and 49-2 may be beveled and lie flush with distalend 35 of needle 31. The proximal ends 53-1 and 53-2 of fibers 49-1 and49-2, respectively, may extend proximally beyond proximal end 33 ofneedle 31 and may be coupled to connectors 55-1 and 55-2, respectively.Examples of connectors suitable for use as connectors 55-1 and 55-2include SMA 905 connectors.

Injection needle 13 may further comprise a spacer 56, spacer 56 beingpositioned within bore 37 of outer needle 31. Spacer 56, which may bemade of a suitable medical grade plastic or the like, may include anelongated, unitary, solid member that is appropriately dimensioned tokeep fibers 49-1 and 49-2 spaced apart at a desired distance. Spacer 56has a distal end 57 and a proximal end 58. Preferably, distal end 57 isbeveled and lies flush with beveled distal end 35 of needle 31. In thepresent embodiment, proximal end 58 is blunt and lies flush with bluntproximal end 33 of needle 31; however, it should be understood thatproximal end 58, if flexible, could extend proximally beyond bluntproximal end 33 of needle 31.

Injection needle 13 may further comprise a bonding material 59, whichmay comprise an optical bonding material, such as an optical epoxy orlike material. Optical bonding material 59 is provided to fill theremaining spaces within bore 37 of outer needle 31 and to bond togetherthe various components positioned within bore 37. The distal end 60 ofoptical bonding material 59 is shaped to lie flush with beveled distalend 35 of needle 31.

Injection needle 13 further comprises an inner catheter 61. In thepresent embodiment, inner catheter 61 may include an elongated, unitary,flexible member, for example, made of a suitable medical grade plastic,inner catheter 61 being shaped to include a proximal end 63, a distalend 65 and a longitudinal bore 67. Proximal end 33 of needle 31 may bedisposed within bore 67 of inner catheter 61 and may be securelyretained therewithin by a tubular band 69 crimped around the outside ofcatheter 61 against needle 31, with distal end 35 of needle 31 extendingdistally a short distance from distal end 65 of catheter 61.

Injection needle 13 may further comprise an outer catheter 71. In thepresent embodiment, outer catheter 71 may include an elongated, unitary,flexible member, for example, made of a suitable medical grade plastic,outer catheter 71 may be shaped to include a proximal end 73, a distalend 75 and a longitudinal bore 77. Outer catheter 71 may beappropriately dimensioned to receive inner catheter 61 coaxially withinbore 77, with inner catheter 61 and outer catheter 71 may be slidablerelative to one another. In this manner, as will be discussed furtherbelow, outer needle 31, as well as the various components housedtherewithin, may be alternately extended distally from outer catheter71, as when making an injection, and retracted into outer catheter 71,as when not making an injection.

Injection needle 13 may further comprise an outer hub 81. In oneembodiment, outer hub 81 comprises an elongated, unitary, tubular, rigidmember, for example, made of a suitable medical grade plastic, outer hub81 may be shaped to include a distal stem portion 83, an intermediateshoulder portion 85, and a proximal collar portion 87. Stem portion 83may have has an outer profile that is generally cylindrical and furthermay comprise a pair of opposing flattened surfaces 89-1 and 89-2 thatextend longitudinally. Shoulder portion 85 may have an outer profilethat is generally conical, tapering outwardly from stem portion 83 tocollar portion 87. Collar portion 87, which may be generally cylindricalin outer profile, may be shaped to include embossed indicia 91-1 and91-2, the purpose of which will be discussed further below. Alongitudinal bore may be provided in outer hub 81, said longitudinalbore comprising a first portion 93, a second portion 94, a third portion95, a fourth portion 96, and a fifth portion 97. First portion 93 mayextend proximally from distal end 99 of hub 81 to second portion 94.Second portion 94, which may be smaller in diameter than first portion93, may comprise an internal flange 101 provided in stem portion 83.Flange 101 may be appropriately dimensioned so that proximal end 73 ofcatheter 71, which is freely received in first portion 93, may besecurely retained within outer hub 81. Outer hub 81 may be insert-moldedaround proximal end 73 of outer catheter 71, with internal flange 101being sized to frictionally engage catheter 71 in a highly retentivemanner. Third portion 95, which may extend between second portion 94 andfourth portion 96, may be greater in diameter than each of first portion93 and second portion 94. Fourth portion 96, which may be located withinshoulder portion 85 and which may extend between third portion 95 andfifth portion 97, may be greater in diameter than each of third portion95 and fifth portion 97. A washer 103 may be fixedly mounted withinfourth portion 97, washer 103 having a generally oval aperture 104, thepurpose of which will be described below. If desired, outer hub 81 maybe insert-molded around washer 103. Fifth portion 97, which may besmaller in diameter than fourth portion 96 but may be greater indiameter than third portion 95, may extend proximally from fourthportion 96 to proximal end 105 of hub 81.

Injection needle 13 may further comprise an inner hub 111. In thepresent embodiment, inner hub 111 may include an elongated, unitary,tubular, rigid member, for example, made of a suitable medical gradeplastic, inner hub 111 being shaped to include a distal stem portion113, an intermediate neck portion 115 and a proximal body portion 117.Stem portion 113, which may be generally cylindrical in outer profile,except for a pair of opposing flattened surfaces 118 that may extendlongitudinally, may be shaped'to include a slotted distal section 119and a tubular proximal section 120. Distal section 119 may have abifurcated barb 121 at its distal end. Proximal end 63 of inner catheter61 may be fixedly mounted within slotted distal section 119 of stemportion 113 by a friction fit. (If desired, slotted distal section 119may be provided with serrations to help grip inner catheter 61.) Tubularproximal section 120 may be shaped to include a longitudinal bore 122and a pair of proximal notches 124-1 and 124-2 along its outer surface.Stem portion 113 may be partially inserted into outer hub 81, with barb121 being appropriately sized relative to aperture 104 of washer 103 sothat barb 121 may be inserted through aperture 104 during assembly ofinjection needle 13 but, thereafter, cannot easily be withdrawnproximally through aperture 104. In addition, tubular proximal section120 may be dimensioned relative to aperture 104 of washer 103 so that,when stem portion 113 and aperture 104 are properly alignedrotationally, proximal section 120 may be moved back and forth throughaperture 104 and so that, when stem portion 113 is fully inserted intoouter hub 81 (with notches 124-1 and 124-2 disposed within aperture104), stem portion 113 may be rotated 90 degrees relative to aperture104, thereby preventing proximal section 120 from being movedtranslationally relative to outer hub 81.

Neck portion 115, which may be generally cylindrical in outer profile,may be shaped to include a longitudinal bore 127, bore 127 being alignedwith bore 122 of proximal section 120. Neck portion 115 may beappropriately dimensioned to serve as a stop to limit insertion of innerhub 111 into outer hub 81.

Proximal body portion 117, which may be generally rectangular in outerprofile, may be shaped to include an unbranched distal portion, i.e., afirst arm 131, and a branched proximal portion, i.e., second and thirdarms 133 and 135, respectively. First arm 131 may be shaped to include abore 137, bore 137 being aligned with bore 127 of neck portion 115.Embossed indicia 139-1 and 139-2 may be provided on opposing surfaces offirst arm 131, indicia 139-1 and 139-2 being provided to be alignablewith indicia 91-1 and 91-2, respectively, to indicate the rotationalalignment of inner hub 111 to outer hub 81, such as when one wishes toprevent longitudinal movement of inner hub 111 relative to outer hub 81.Second arm 133, which is substantially coaxial with first arm 131, maybe shaped to include a bore 141, bore 141 being aligned with bore 137 offirst arm 131. The proximal end of second arm 133 may be shaped toinclude an externally threaded connector 143 adapted for use with aneedle-less syringe or the like. Third arm 135, which may lie off-axiswith first arm 131, may be shaped to include a bore 145, bore 145communicating with bore 137. A flexible strain relief 150 is coaxiallymounted over the free end of third arm 135.

Injection needle 13 may further comprise a sheath 151. Sheath 151 may bean elongated, unitary, flexible, tubular member, for example, a lengthof furcation tubing. Sheath 151 may be shaped to include a proximal end153 and a distal end 155, proximal end 153 being bifurcated into arms154-1 and 154-2 to hold the proximal ends of optical fibers 49-1 and49-2, respectively. Distal end 155 of sheath 151 may be fixedly mountedwithin strain relief 150.

Light source 15, which may be a conventional, variable-wavelength lightsource (e.g., tunable laser, lamp with filters, etc.) of the type usedto illuminate objects with one or more of ultraviolet, visible andinfrared light for purposes of performing optical spectroscopy, may becoupled to connector 55-2 to provide light to optical fiber 49-2.

Spectrometer 17, which may be a conventional spectrometer, may becoupled to connector 55-1 to detect the light from optical fiber 49-1.Spectrometer 17 may also be electrically coupled to computer 19, which,in one embodiment, compares the detected spectrum to standards fromobjects whose composition is known (e.g., fat tissue, muscle tissue,blood, etc.). The results of the comparison from computer 19 may then betransmitted to indicator 21. Indicator 21 may take the form of acomputer monitor, a printer, one or more light signals (e.g., a greenlight turned on for targeted objects, a red light turned on for otherobjects), one or more audio signals (e.g., a bell rung for targetedobjects, a buzzer actuated for other objects), or the like.

To use assembly 11, for example, to inject implant material into thelower esophageal sphincter of a patient, one may first insert the distalend of an endoscope through the mouth of the patient and then into theesophagus of the patient in the vicinity of the lower esophagealsphincter. Placement of the distal end of the endoscope in the vicinityof the lower esophageal sphincter may be aided by real-time observationequipment loaded into a viewing channel of the endoscope. Then, one mayattach a solution-containing syringe to connector 143 of injectionneedle 13 and may load the distal end of injection needle 13 into theworking channel of the endoscope, with needle 31 being placed in aretracted position within outer catheter 71. Next, one may extend needle31 distally from outer catheter 71 by sliding inner hub 111 into outerhub 81 until neck portion 115 of inner hub 111 abuts washer 103. Onethen may rotate inner hub 111 relative to outer hub 81 by 90 degrees(i.e., so that indicia 91-1 and 91-2 are aligned with indicia 139-1 and139-2, respectively) to keep inner hub 111 and outer hub 81 from slidingrelative to one another. With needle 31 thus extended distally fromouter catheter 71, one may begin to insert needle 31 into a targetedarea of the patient. (Visual identification of the targeted area ispreferably aided by the real-time observation equipment of theendoscope.) As needle 31 is inserted into the targeted area, light fromlight source 15 may be transmitted to the penetrated depth of thetargeted area using optical fiber 49-2. The light reflected from theilluminated area may then be collected by optical fiber 49-1, may bedetected by spectrometer 17, and may be analyzed by computer 19. Theresults of the comparison may then be transmitted to indicator 21, whichmay provide an indication (e.g., visual, aural, etc.) as to whetherneedle 31 has been inserted into the area to an appropriate depth (e.g.,to the depth at which muscle tissue is located). As can be appreciated,the aforementioned spectroscopic testing of the illuminated area may beconducted continuously so that, as one inserts needle 31 into the areato changing depths, one may obtain virtually instantaneous feedback asto whether needle 31 is positioned at the appropriate depth for thedesired tissue type within the targeted area. Once an indication hasbeen made that needle 31 has been inserted into the desired tissue type,one may dispense the solution from the syringe into the tissue usinginjection needle 13, the solution being conducted successively throughbores 141, 137, 127, 122, 67 and 47, respectively. After the injectionis complete, one may retract needle 31 into catheter 71 by rotatinginner hub 111 relative to outer hub 81 by another 90 degrees (i.e., sothat indicia 91-1 and 91-2 are 90 degrees out of alignment with indicia139-1 and 139-2) and by sliding inner hub 111 proximally away from outerhub 81 until barb 121 of distal. portion 113 abuts washer 103. One thenmay remove injection needle 13 and the endoscope from the patient.

Referring now to FIG. 6, there is shown an enlarged section view of analternate needle assembly adapted for use in injection needle 13, saidalternate needle assembly being represented generally by referencenumeral 201.

Assembly 201 is similar in many respects to the needle assembly ofinjection needle 13, assembly 201 including (i) an outer needle 203 thatis similar to outer needle 31, (ii) an inner needle 205 that is similarto inner needle 41, and (iii) an optical bonding material 207 that issimilar to optical bonding material 59. However, assembly 201 differsfrom the needle assembly of injection needle 13 in that, instead ofincluding spacer 56 and optical fibers 49-1 and 49-2, assembly mayinclude fiber optic assembly 211. Assembly 211, which is shownseparately in FIGS. 7( a) and 7(b), comprises a pair of optical fibers213-1 and 213-2. Fibers 213-1 and 213-2 may be similar in structure andcomposition to optical fibers 49-1 and 49-2, respectively, each offibers 213-1 and 213-2 comprising a core 215, a cladding 217 and abuffer 219. Assembly 211 also may comprise a bundling sheath 221,bundling sheath 221 designed to coaxially surround each of fibers 213-1and 213-2 at their respectively distal ends and physically couplingtogether fibers 213-1 and 213-2. In the present embodiment, sheath 221may be made of a flexible material so that fibers 213-1 and 213-2 mayassume an orientation within needle 203 similar to that assumed byfibers 49-1 and 49-2 within needle 31.

In another embodiment (not shown), the light source and/or the lightdetector may be positioned at or near the distal end of the injectionneedle. For example, an LED or other light source may be positioned ator near the distal end of the hollow needle, and a light sensor may belocated on. the outside of the hollow needle or integrated into the wallof the hollow needle. Alternatively, the needle itself could be anoptical light guide, either to deliver light or to receive light.

It should be noted that, although the endoscopic injection needleassembly of the present invention has been described above as being usedto inject implant material into LES tissue, this assembly is not limitedto injecting implant materials nor is it limited to injecting materialsinto LES tissue. For example, it may include use as a needle to injecttherapeutic and/or diagnostic agents and implants.

The embodiments of the present invention described above are intended tobe merely exemplary and those skilled in the art shall be able to makenumerous variations and modifications to it without departing from thespirit of the present invention. For example, it should be understoodthat, instead of using one optical fiber to illuminate an object andanother optical fiber to collect the light reflected from the object,one could use an arrangement that includes a single optical fiber forboth illumination and collection. All such variations and modificationsare intended to be within the scope of the present invention as definedin the appended claims.

1-25. (canceled)
 26. A method of evaluating a tissue, the methodcomprising the steps of: inserting a first hollow needle into aninsertion site of a body part to a first depth, the first hollow needleextending distally from the distal end of a first catheter and having asharp distal end adapted for insertion into the body part, the firsthollow needle including a tubular member disposed within a lumen of thefirst hollow needle, the tubular member having a longitudinal bore,wherein each of the first catheter and the tubular member is configuredto directly contact and allow fluid to flow from the longitudinal boreof the first catheter to the longitudinal bore of the tubular member;and injecting a material through the tubular member and into the bodypart.
 27. The method of claim 26, wherein the first hollow needle isaxially fixed relative to the tubular member.
 28. The method of claim26, wherein the tubular member is a second hollow needle.
 29. The methodof claim 28, wherein the second hollow needle has a distal-facing distalend face, the distal-facing distal end face of the second hollow needleand a distal-facing distal end face of the first hollow needle lyingalong a common plane.
 30. The method of claim 26, wherein a bondingmaterial is disposed within the first hollow needle.
 31. The method ofclaim 30, wherein the bonding material includes epoxy.
 32. The method ofclaim 30, wherein a distal end of the bonding material includes a distalface configured to lie flush with the distal end of the needle.
 33. Themethod of claim 26, wherein the first hollow needle has a proximal end,the proximal end being fixedly mounted within the longitudinal bore ofthe first catheter.
 34. The method of claim 26, wherein a secondcatheter includes a proximal end, a distal end, and a longitudinal bore,the first catheter being slidably mounted in the second catheter. 35.The method of claim 34, further comprising: extending the first needleand the first catheter relative to and distally of the second catheter.36. The method of claim 34, further comprising: placing a syringe influid communication with the tubular member, wherein the syringeincludes material.
 37. The method of claim 34, wherein inserting a firsthollow needle includes inserting a first hollow needle transorally. 38.A method of evaluating a tissue, the method comprising the steps of: (a)inserting a hollow needle into an insertion site of a body part to afirst depth, the first hollow needle extending distally from the distalend of a first catheter and including a tubular member disposed within alumen of the first hollow needle, the tubular member having alongitudinal bore, wherein a proximal end of the tubular member ispositioned to allow fluid to flow from the first catheter to thelongitudinal bore of the tubular member; (b) illuminating the body partat the first depth; and (c) detecting the light reflected from theilluminated body part at the first depth.
 39. The method of claim 38,further comprising: repeating steps (a) through (c) for other depths orother insertions sites.
 40. The method of claim 38, wherein the bodypart is illuminated using light transmitted through fiber optics locatedradially outward from the tubular member.
 41. A method of treating atissue, the method comprising the steps of: (a) inserting a needle intoan insertion site of a body part within a digestive tract to a firstdepth; (b) illuminating the body part at the first depth; (c) detectingthe light reflected from the illuminated body part; (d) comparing thedetected light to a standard of a known composition; and (e) indicatingthe results of the comparison.
 42. The method of claim 41, furthercomprising: repeating steps (a) through (e) for other depths or otherinsertions sites until a predetermined type of tissue is located. 43.The method of claim 42, further comprising: injecting a material throughthe tubular member and into the predetermined type of tissue.
 44. Themethod of claim 41, wherein step (b) is performed using lighttransmitted through fiber optics disposed within the needle, and step(c) is performed using a light detector operatively coupled to the fiberoptical fibers.
 45. The method of claim 41, wherein the first hollowneedle including a tubular member disposed within a lumen of the firsthollow needle, the first hollow needle including fiber optics disposedwithin the first hollow needle and radially outward from the tubularmember, for transmitting light to an object and for collecting lightreflected from the object.